1
Feasibility of HIV Point-of-Care tests for Resource Limited Settings: Challenges and
2
Solutions
3
W.S. Stevens (1,2), N. Gous (1), N. Ford (3), L.E. Scott (1)
4
Affiliations: 1. Department of Molecular Medicine and Haematology, Faculty of Health Sciences,
5
University of the Witwatersrand, Johannesburg, Gauteng, South Africa
6
2. National Health Laboratory Service and National Priority Program
7
3. Department of HIV/AIDS, World Health Organization, Geneva, Switzerland
8
9
Abstract
10
Improved access to anti-retroviral therapy (ART) increases the need for affordable monitoring
11
using assays such as CD4 and/or viral load (VL) in resource-limited settings. Barriers to accessing
12
treatment, high rates of loss to initiation and poor retention in care are prompting the need to
13
find alternatives to conventional centralized laboratory testing in certain countries. Strong
14
advocacy has led to a rapidly expanding repertoire of Point-of-Care tests for HIV. Point of Care
15
testing (POCT) is not without its challenges: poor regulatory control, lack of guidelines, absence
16
of quality monitoring and lack of industry standards for connectivity, to name a few. The
17
management of HIV increasingly requires a multidisciplinary testing approach involving
18
hematology, chemistry and tests associated with the management of non-communicable
19
diseases, thus added expertise is needed. This is further complicated by additional human
20
resource requirements, the need for continuous training, sustainable supply chain and
21
reimbursement strategies. It is clear that to ensure appropriate national implementation either
22
in a tiered laboratory model or a total de-centralized model, clear country-specific assessments
23
need to be conducted.
24
Keywords
25
Anti-retroviral therapy; Point-of-Care; HIV; implementation; challenges; CD4; viral load
26
27
Introduction
28
Globally, the numbers of persons living with HIV have increased from 34 million [31.4–35.9
29
million] in 2011, to an estimated 35.3 million [32.2 – 38.8 million] in 2012; approximately 69% of
30
the global HIV burden resides in sub-Saharan Africa [1]. In response to anti-retroviral therapy
1
1
(ART) programs, a concurrent drop in AIDS related deaths from 2.3 million [2.1-2.6 million] in
2
2005 to 1.6 million [1.4-1.9 million] in 2012, have been recorded [1]. In order to reach the
3
expected 2020 goals, a massive increase in HIV testing capacity will be required.
4
The expansion of ART programs can only be described as a huge success in low and middle-
5
income countries. Estimates reached 9.7 million on ART at the end of 2012, representing some
6
60% of those in need at that time [2]. With the new WHO guidelines changing the CD4 test
7
threshold for treatment initiation from mid-2013, the numbers of HIV infected individuals
8
potentially requiring access to treatment has increased to an estimated 28.6 million [1].
9
Challenges to continued ART scale up remain and include: improving access to HIV testing;
10
ensuring universal access; earlier initiation of treatment by improved access to HIV testing;
11
ensuring subsequent linkage- to- care and finally long-term retention in care. Each phase of HIV
12
diagnosis and monitoring is supported by a number of tests conducted according to different
13
algorithms in many high burden countries, each with human and technical resource
14
requirements. HIV rapid tests, used in adults in serial or parallel algorithms using 1-3 different
15
assays, have been instrumental in ensuring wide-scale diagnosis and access to care, albeit with
16
ongoing challenges to ensure quality. A recent estimate from PEPFAR countries suggests over 80
17
million HIV rapid assays were performed in 2013 and that 11% of all assays were conducted as
18
point-of-care (POC) tests (Jason Williams, personal communication).
19
CD4 testing has been the gatekeeper for assessing immune status and establishing eligibility for
20
treatment and care. Treatment eligibility threshold levels have changed over time from 200
21
cells/μl in 2002 [3] to 350 cells/μl in 2010 [4] and more recently the new consolidated WHO
22
recommendations suggest initiation at CD4 counts of <500/μl [5]. Further suggestions of
23
universal access and test and treat strategies are also being evaluated and hotly debated [6].
24
The latter approach is already occurring for certain high risk population groups such as those co-
25
infected with tuberculosis (TB), pregnant women and children under 5 years of age. CD4 count
26
has also been used for regular monitoring of immunological recovery on treatment, generally at
27
6 monthly intervals. CD4 testing can be done at different tiers of the laboratory service [7] and
28
the frequent delay in linking this assay to the initiation of patient care can result in significant
29
loss to follow up [8]. CD4 testing is also recommended by WHO and used in South Africa as a
30
benchmark for establishing the risk of cryptococcal infection, where testing for cryptococcal
31
antigen can now be done at POC and prevents the onset of meningitis, if treated with
2
1
fluconazole [9].
2
The HIV viral load (VL) assay, a nucleic-acid based test, is used to monitor response to treatment
3
and an undetectable viral load defines treatment success. VL testing is frequently done in
4
centralized facilities and currently requires expensive instrumentation, technical skill and
5
relatively high costs per assay. Despite these challenges, this assay has gained its rightful place in
6
guidelines and clinical practice and is thought to be the most reliable marker for treatment
7
success [10, 11].The development pipeline of POC viral load assays promises to deliver a number
8
of options to improve access and facilitate earlier identification of treatment failure. This will
9
allow clinicians to avoid premature switching of regimens particularly in regions with limited
10
drug availability, potentially improving patient adherence and reducing the development of drug
11
resistance [12]. Also, the percentage of failures using this assay can provide a monitor of both
12
individual and program success [13]. As access to viral load testing is improving, the role of CD4
13
measurements is being reassessed. Numerous studies have demonstrated that for the vast
14
majority of people living with HIV who are receiving ART and are virally suppressed, CD4 cell
15
count does not decline over time [14]. Other studies have shown that one third of individuals
16
whose CD4 count was greater than 350cells/ul had viral loads greater than 100,000 HIV RNA
17
copies/ml [15]. A meta-analysis of seven studies assessing the accuracy of clinical or CD4 tests in
18
predicting virological failure found a poor sensitivity of 26.6% and a positive predictive value of
19
49.4% [11]. This suggests that in situations where viral load is available routinely, CD4
20
monitoring can be reduced in frequency or stopped altogether. Recognizing this opportunity to
21
save resources, the South African ART guidelines in 2013 recommended stopping routine CD4
22
monitoring in people who are stable on ART and a number of other countries are considering
23
moving in this direction [16].
24
In addition to the core assays described in HIV individuals, there are also hematology and
25
biochemistry assays that remain important, including hemoglobin, creatinine (especially for
26
tenofovir initiation), liver transaminase tests as well as assays for the diagnosis of opportunistic
27
infections such as tuberculosis and cryptococcal infection. The diagnosis and treatment of
28
tuberculosis is critical in low and middle- income countries where a significant proportion of HIV
29
infected individuals are co-infected with tuberculosis. In South Africa as an example, co-infection
30
rates are as high as 65-70% [17].
3
1
To address all the needs described above and in the face of the successes of rapid tests such as
2
those for HIV, malaria and more recently cryptococcal antigen, there is a drive now towards
3
using POCT for the non-communicable diseases such as diabetes, cardiovascular disease and
4
cancer, many of which are associated with long-term management of people living with HIV.
5
Thus, there is an expanded list of multi-disciplinary testing needs at primary health clinics (PHC).
6
Performing and interpretation of these tests will potentially require significantly more expertise
7
than a single rapid HIV antibody test.
8
History of point- of- care testing
9
POCT is an old approach to testing that has been around for decades and remains as
10
controversial today as it was when first introduced. POCT refers to testing that is performed
11
near or at the site of patient with the result leading to a possible or immediate change to patient
12
care [18]. The rationale is largely based on a need for shortening the time to decision-making.
13
The literature provides a myriad of different definitions such as the Clinical Laboratory
14
Standards Institute (CLSI) in the USA that defines the purpose of POCT being the provision of
15
timely results that clinically and cost-effectively contribute to management decisions [19]. The
16
first references to POCT date back to the early 1990s and focused largely on glucose testing for
17
diabetes and blood gas analyzers in intensive care units and operating theatres [20]. The
18
controversy around managerial, quality and regulatory ownership remains a problem and it has
19
been suggested that this is still a “work in progress” [21]. Despite this, POCT is the fastest
20
growing segment of the diagnostic industry (10-14% annually) accounting for 1 in 4 tests within
21
the developing world [22, 23]. A recent review reported that POCT accounts for 25% of total
22
laboratory revenue [24]. New diagnostics into which POCT has expanded include cardiac
23
markers, coagulation assays, substance abuse and home-based HIV testing, to name a few [25].
24
Interestingly, POC devices include not only ex vitro but also in vitro and in vivo methodologies
25
(continuous monitoring devices) [26]. Technological advances such as microfluidics [27],
26
miniaturization [28], micro-fabrication, simple power and affordable light sources and
27
electromagnetic actuation of fluids using micro-electronics and more recently nanodiagnostics
28
[29, 30], have facilitated the development of more complex assays capable of placement at the
29
POC [28]. Thus, rapid tests described for HIV diagnosis have been described as first generation
30
POC assays involving antigens and antibodies and simple biochemistry and haematology; the
31
second generation is infinitely more complex and based on cell detection or nucleic acid
4
1
amplification and detection and finally the third generation complex analyzers that could have
2
multiplexing capabilities [31].
3
Global Perspective on POCT
4
The unmet laboratory needs for assays to address communicable diseases such as HIV, TB and
5
malaria, appear to have assisted in catalyzing the POC diagnostics industry as a whole. Both
6
communicable and non-communicable diseases will in future reap the benefits as appropriate
7
implementation strategies are developed [31]. This is particularly important when predictions
8
for the future suggest that diabetes may well be a more important risk factor for TB than HIV.
9
Global market assessments have suggested that the increase in diabetes and thus glucose
10
testing comprises at least 10% of the global POCT market [32]. The growth in POC HIV testing
11
has been further reinforced by strong advocacy from groups such as the World Health
12
Organization (One pillar of Treatment v2.0 guideline, WHO 2013 treatment guidelines), UNITAID
13
(market catalysts; Geneva), the Bill and Melinda Gates Foundation (BMGF, Seattle), the Clinton
14
Foundation, PEPFAR, and African Society of Laboratory Medicine (ASLM), who have been tasked
15
with promoting guidance and implementation in field sites. This drive has begun to address
16
many of the factors mentioned above, such as the absence of laboratories or access to assays
17
such as CD4 and viral load testing for the diagnosis and monitoring of HIV in remote sites.
18
Alternatives to conventional centralized testing are being driven by the high rates of loss to
19
initiation for both HIV and TB, as well poor retention in care [33]. These activities have catalyzed
20
funders, suppliers, users and patients in galvanizing the POC diagnostics industry into action. In
21
addition, POCT has been incorporated into the Global Health Strategy on HIV/AIDS. Both the
22
WHO and the London School of Tropical Medicine and Hygiene (LSTMH) have been tasked with
23
bringing forward multi-center laboratory- based validations of POC assays followed by
24
evaluation of their implementation in the field [34]. A strong emphasis has also been placed on
25
the need for monitoring the impact and cost of the interventions across the entire continuum of
26
care. By nature of the low throughput of these technologies and the additional human resources
27
required in the field for testing and maintenance, the total assay costs can be as, or more
28
expensive as laboratory testing. A strong emphasis needs to be placed on innovative strategies
29
for ensuring quality for tests that are being conducted in volumes far beyond that covered by
30
conventional laboratory quality assurance plans and accreditation status. In South Africa, there
31
is an ISO standard (ISO22789) that has been implemented for accredited laboratories to follow if
5
1
they are conducting and supporting POC testing [35]. Perhaps a similar approach to
2
accreditation of clinic sites conducting POC testing with a simpler standard and checklist could
3
be used to ensure quality is maintained in field-testing sites.
4
The pipeline for HIV diagnosis and monitoring
5
There is an ever-expanding pipeline associated with the strong advocacy for POCT from global
6
players, who maintain that universal access for HIV and TB care requires the use of POCT for
7
earlier testing and improved retention in care. Cited advantages of POCT include improved
8
turnaround time, greater accessibility, potentially improved patient retention and possible
9
reduction in overall health care costs. However, despite the rapid growth and interest in POCT,
10
many aspects remain controversial, in part because this approach challenges the conventional
11
approach to laboratory testing, which remains the prevailing paradigm in many countries. In
12
addition, while numerous early or near market entry products are available, there were few that
13
in early 2014 could be purchased on a large-scale, outside of rapid HIV and malaria strip based
14
tests, and a monopoly of one or two suppliers with a proven track record for CD4 testing such as
15
the PIMA assay (Alere Inc., Waltham, MA, USA) exists. In the viral load arena, numerous early
16
market entry products are available and development has been heavily funded, yet only 3 were
17
available for clinical validation as of April 2014 - the LIAT™ Analyser (IQuum, Inc.) [36], AlereTM Q
18
HIV-1/2 Detect (Alere) [37] and Samba (Diagnostics for the Real-World, Ltd) [38] and
19
manufacturing track records for scale-up are not available. The upcoming pipeline for HIV CD4
20
and VL testing with their performance characteristics are summarized in the landscape
21
document produced annually by UNITAID [12]. A plethora of fast followers are in various stages
22
of research and development and evaluation and include the MBio POC CD4 (MBio Diagnostics,
23
Inc) [39], Daktari CD4 Counter (Daktari Diagnostics, Inc), FACSCprestoTM (BD Biosciences) [40],
24
Visitect® (Omega Diagnostics), Zyomyx CD4 (Zyomyx, Inc) and EMD Millipore® MuseTM (Merck)
25
[12]. For viral load testing, these include the GeneXpert® viral load system (Cepheid, Sweden) ,
26
the EOSCAPE-HIVTM Rapid RNA assay system (Wave 80 Biosciences) [41], TrueLabTM Real time
27
micro PCR system (MolBio Diagnostics, Ltd), Savanna viral load test and platform (Northwestern
28
Global Health Foundation in collaboration with Quidel Corporation) and the Bioluminescent
29
Assay in Real Time technology (Lumora, Ltd.) [42], amongst others [12].
30
In countries where significant laboratory infrastructure currently exists in both the public and
6
1
private sectors, the sheer volumes of testing may make total decentralization prohibitive in
2
terms of instrumentation and human resource requirements. In these instances, POC assays
3
may and do have a role to play where gaps in service are noted and these can be identified by
4
approaches such as GIS (Geographic Information Systems) mapping to ensure a national total
5
coverage model. The total coverage model is a new term being used in laboratory testing circles
6
which refers to a tiered implementation model that includes both POC testing and different tiers
7
of laboratory testing to ensure access for the entire national population. POC tests are also used
8
heavily in specific niche areas such as hemoglobin in emergency rooms or renal clinics. A
9
particular niche for the viral load assay could for example, be in the maternity wards and
10
antenatal care (ANC) clinics where pregnant HIV infected mothers could be monitored for risk of
11
transmission and success of treatment strategies, and exposed infants could be tested at birth
12
for HIV and then treatment initiated as soon as possible.
13
Major issues surrounding the implementation of POCT exist and include poor regulatory control,
14
difficulties in ongoing monitoring of quality and limited availability of guideline documents for
15
the safe implementation of POC devices. In addition, there are few studies that report data on
16
full economic costing for POC [43], which is likely to vary depending on tests used, diseases
17
investigated and model input parameters.
18
There is a dearth of well -designed randomized, controlled clinical trials (RCT) to evaluate the
19
outcomes and impact of the implementation of POCT. Most notable for their contributions to
20
the POC literature are a group led by Shephard in Australia [44, 45]. Although evaluating other
21
assays in a general practitioner setting in Australia, the final study conclusions were that POCT
22
was not inferior to laboratory based testing, but came at a substantially higher cost that needs
23
to be weighed against overall health benefits. Various clinical experiences were presented at a
24
recent forum held in South Africa with a number of studies reporting progress in RCT studies
25
such as the Home-based Care Plus trial in Kwazulu-Natal, Rapid Initiation of Anti-retrovirals in
26
Pregnancy (RAP) study in Cape Town, the Grand Challenges Canada RCT and RapIT (Midrand
27
PHC, South Africa). Results are still awaited eagerly and will help form policy but have shown
28
clearly that POCT is just one step
in a multi-step process along the continuum of care [46].
29
Other experiences showed that POCT had great potential for certain high-risk populations such
30
as migrants or adolescents where loss to follow up is high and where immediate results would
31
add value [46].
7
1
Pilot studies on the implementation of PIMA CD4 POC testing in South Africa and Mozambique
2
have demonstrated that time to initiation was reduced however, challenges were identified in
3
that nurses perceived POC implementation as additional workload, and that patients migrated
4
from facilities before staff were able to track, record and file the results in patient’s folders [46].
5
Experiences from Mozambique showed that after the introduction of POC CD4, the loss- to-
6
follow up before CD4 staging dropped, ART initiation rate increased and time to ART initiation
7
was reduced from 48 days to 20 days [47]. Retention rates in care however, remained the same.
8
It was recommended by this group that deploying POC should be done in co-existence with
9
conventional testing as part of a total laboratory network and
there was acknowledgement that
10
POC testing is far from error -proof. Only 20% of Mozambique’s CD4 counts are conducted at
11
POC. High invalid rates were noted using POC CD4 tests in this study. There was a warning that
12
simple implementation is not always efficient - access does not necessarily mean that the
13
patient gets care (approximately 25% of patients did not get CD4 testing even with POCT on site)
14
- and it was highlighted that significant health systems strengthening is needed and clinic
15
workflow re-engineering. A meta-analysis of the performance of PIMA is underway and
16
preliminary analysis revealed performance of instrument on venous specimens is as good as
17
current gold standard technology. However, performance on capillary derived specimens
18
showed increased variability at the 350cells/μl threshold resulting in higher false positive rates
19
which would lead to more patients being placed on ART (unpublished results).
20
Approaches to ensuring quality testing
21
FDA requirements for defining a simple test are that it should be rapid, easy to perform, require
22
minimal training, no specialized laboratory setup and reagents should be stable and
23
temperature independent; however, few assays actually meet these requirements. It should be
24
noted that assay transfer from the laboratory to POC is not synonymous with improved quality
25
of care. Implementation at the POC will require facilitation in a step-wise fashion with careful
26
monitoring and evaluation at each step. The approach to quality of rapid lateral flow-based
27
assays will be different to those that are device based. Several guidelines for HIV rapid testing
28
have been written over the years, but uptake of these recommendations has been poor in most
29
resource-limited settings. In fact, many of these assays are considered CLIA (Clinical Laboratory
30
Improvement Amendment) waived as they are simple tests with a low risk for an incorrect result
31
and are thus not quality assured in developed countries such as the USA.
8
1
While programs such as the WHO pre-qualification process [48] have provided guidance by
2
conducting product and supplier evaluations and validations, and the Center for Disease Control
3
and Prevention (CDC) has done similar work for PEPFAR related programs, there is a need for
4
harmonization of approaches and standardization of protocols with greater co-operation
5
between stakeholders. There needs to be co-ordination and review of all strategies and
6
guidelines so that a simple, single guidance can be provided for countries. Quality needs to be
7
addressed, within the laboratory and at the pre-analytic, analytical and post-analytical phases
8
[22]. For rapid assays, the sheer volumes of assays conducted make conventional internal and
9
external quality approaches extremely difficult to implement. Strategies employed have
10
included the use of EQA material using dried tube spots for various HIV rapid assays [49] or
11
dried culture spots for near point-of care TB testing [50, 51]. Innovative strategies are required
12
for material distribution and data collection across large programs. Regular training and re-
13
training, competency assessments and ongoing supervision and mentoring of staff conducting
14
assays are all critical to ensuring continuous maintenance of quality.
15
For device-based assays, an approach that is under scrutiny is the use of real-time continuous
16
monitoring using various connectivity systems linked to analyzers in the field [52, 53].
17
Connectivity provides not only a means to ensure analyzer performance meets requirements,
18
but also provides a means of collecting programmatic data, distribution of results, and
19
identifying the need to intervene should problems arise. Data ownership and data security are
20
issues that need to be addressed. Each analyzer however, frequently connects to the
21
middleware or software solution via a different mechanism currently and there is thus a need
22
for industry standards for POCT connectivity [54]. Several middleware programs have been
23
evaluated that link to laboratory information systems in South Africa with success, although
24
approaches differ in different regions depending on wireless availability, internet access and
25
computer literacy. Thus solutions may need to be contextualized within different geographic
26
regions. Simpler approaches may include the use of bi-directional SMS printers with additional
27
capabilities for data collection and acknowledgement of receipt of results [55]. To improve
28
retention in care, patients can be recalled for results and this makes for a reasonably successful
29
means of improving adherence [56]. The role of secondary and tertiary laboratories in the
30
management of quality in PHC clinics is essential and many believe POCT should be a natural
31
extension of the laboratory [57].
9
1
Supply chain management and procurement strategies need to be well planned. Global
2
procurement and global forecasting may play a larger role than for other assays as the
3
production lines for new assays entering the market are frequently unable to meet the demand
4
of rapid recommendations that lead to rapid global uptake. Engagement with industry in the
5
pre-market phase may help to ensure quality features are built into the system, connectivity is
6
considered, and production meets the needs based on information provided on disease
7
prevalence and likely test numbers. UNITAID, as an organization that funds approaches to
8
catalyze and effect market changes, can stimulate additional approaches improving access.
9
Advocacy for quality assured, appropriately selected assays used in settings where impact can
10
be demonstrated is strongly needed.
11
Ownership and Accountability
12
There is a general consensus that ownership should be at the level of in-country Ministries of
13
Health. A POCT policy needs to be embedded within the National Strategic laboratory plan, the
14
development of which was strongly advocated for by the Maputo declaration [58]. A single
15
strategic national plan for introduction of POCT in a country is likely to solicit donor funding or
16
that of local treasuries in a far more effective manner. It is imperative that technical task teams
17
are established to support decision- making. The composition of the team should include
18
clinicians, laboratorians, health economists, procurement, supply and distribution and funders.
19
Strong partnerships with industry need to be facilitated as the ongoing procurement,
20
maintenance of analyzers and product failures need to be addressed. As a result of recent
21
product failures in the HIV arena impacting many countries, a task team was established with
22
expertise from organizations such as the WHO, CDC and other partners that may be useful going
23
forward to address product failures urgently as this body is formalized. This brings in the
24
concept of a far more active reporting to support post-market surveillance, currently poorly
25
coordinated the world over. Ownership of the POCT process, however, needs to extend to users
26
of the assays and the communities that are tested with creative ways developed for
27
incentivizing healthcare workers conducting the tests to maintain high quality standards.
28
Conclusions
29
Point of care testing will improve access to needed HIV and associated diagnostics, but these
30
assays are not without limitations that should be noted and reported. There is a need to
10
1
integrate these technologies cost-effectively and efficiently into clinical algorithms and existing
2
laboratory networks. In costing it should be emphasized that context matters, particularly
3
human resources and test volumes. There is much to be done in this field. Notably, large
4
randomized studies measuring the impact of a diagnostic intervention along the entire
5
continuum of care are an exception and need to be encouraged and supported. Standardization
6
of assay evaluation and development of appropriate internal and external quality control are
7
important activities that need support. Regulatory hurdles need to be overcome and developed
8
in many countries. Global harmonization of all stakeholder activities is essential to get the
9
product from an idea to the bench and ultimately to the patient bedside. The likelihood is that in
10
many countries POCT will be strategically deployed in a hybrid model with support from the
11
conventional tiers of in-country laboratories.
12
13
14
15
16
17
18
19
20
21
22
23
24
25
List of abbreviations
ART
Antiretroviral Therapy
POC
Point of Care
POCT Point of care testing
HIV
Human immunodeficiency virus
GIS
Geographic Information Systems
TB
tuberculosis
PHC
Primary Health-Care Clinic
ASLM African Society of Laboratory Medicine
BMGF Bill and Melinda Gates Foundation
PEPFAR President’s Emergency Plan for AIDS Relief
RCT
Randomized Control Trial
26
EQA
External Quality Assurance
27
FDA
US Food and Drug Administration
28
CDC
Center for Disease Control and Prevention
29
WHO
World Health Organization
30
SMS
Short Message Service
31
CLIA
Clinical Laboratory Improvement Amendment
32
33
11
1
Competing interests: None
2
3
Authors’ contributions
4
5
WS wrote the first draft of the manuscript.
6
LS and NG did a review of the manuscript; both are involved in POC projects in the National
7
HIV/TB program in South Africa and provided information.
8
NG assisted with sourcing references.
9
NF reviewed the document.
10
All authors have read and approved the final manuscript.
11
12
13
Authors’ information
WS is currently Professor and Head of the Department of Molecular Medicine and
14
Haematology, at the University of the Witwatersrand; and the National Health Laboratory
15
Service (NHLS) from 2003 to current. Her research efforts have been largely focused in HIV for
16
the past 12 years and this can be supported by over 170 peer reviewed publications and 140
17
conference presentations. She has contributed significantly to the development of capacity for
18
affordable, accessible HIV diagnosis and monitoring in South Africa and over 60 centers in sub-
19
Saharan Africa. Research activities have included the expansion of early infant diagnosis of HIV,
20
affordable viral load, CD4 and investigation of HIV drug resistance. Since November 2010, she
21
has been appointed head of National Priority Programs at the NHLS focusing on laboratory
22
efforts related to HIV and TB. Her current roles have included National Rollout of GeneXpert
23
technology across microscopy centers in South Africa. Her current work is the evaluation and
24
validation of POCT, both instruments and positioning thereof within the healthcare system in
25
South Africa.
26
NG is a PhD student, currently holding the position of Medical scientist in the Research and
27
Development Unit in the Department of Molecular Medicine and Haematology. Her main areas
28
of research include the development and evaluation of novel, rapid and affordable HIV and TB
29
diagnostic assays, particularly for use in low resource settings. NG is part of the POC Research
30
Group established by the NHLS National Priority program to investigate integration of HIV/TB
12
1
services at Point of Care and was the R&D scientist involved in the development and production
2
of an EQA and verification program for the NHLS national GeneXpert roll-out program (under
3
LS).
4
NF has worked on improving access to HIV/AIDS treatment and care in resource-limited settings
5
for the last 15 years, with a particular focus on sub-Saharan Africa.
6
LS is an applied scientist in the Department of Molecular Medicine and Haematology, and has
7
for the past 15 years focussed on designing, developing, evaluating and implementing
8
laboratory diagnostic technologies for HIV and TB infected individuals. She has over 50
9
publications, more than 100 abstracts at local and international conferences and is a reviewer
10
for several journals and part of editorial boards within her field. Her more recent innovation is
11
the development of a novel quality monitoring system for the Gene Xpert MTB/RIF test using
12
dried culture spots (DCS) of inactivated Mycobacterium tuberculosis. These developments
13
together with three other WITS patents and one trademark emphasize the contribution of Prof
14
Scott’s research to improving health care in South Africa.
15
16
Acknowledgements
17
Knowledge- base attained through work done with Funds received from Grand Challenges
18
Canada POC implementation grant (grant 0007-02-01-01-01).
19
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References
1.
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